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PCSK9 rivals Amgen and Pfizer angle for AHA spotlight with promising data

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Those hot PCSK9 bad cholesterol drugs elbowed their way to center ring at the American Heart Association meeting, with Amgen ($AMGN) grabbing the spotlight with a fresh batch of positive midstage data on their program for AMG 145.

After 12 weeks of therapy, a group of patients intolerant of statins like Lipitor demonstrated a 51% plunge in LDL. And when the experimental PCSK9 therapy was tied to Merck's Zetia, the drop in bad cholesterol shot up to 63%. Pfizer, meanwhile, reports that RN-316 cut bad cholesterol by 80%, with some patients' LDL levels so low they didn't qualify for a second injection.

For Amgen, the news underscores why some of the world's biggest drug developers are betting huge sums on these PCSK9 programs. Adnan Butt, an analyst with RBC Capital Markets, tells Bloomberg that the market for statin-resistant patients could amount to $10 billion. That's the kind of megamarket that can potentially fill a big hole in Amgen's product lineup as its anemia drugs face growing competition.    

"With these drugs, together with statins, you can get virtually everyone to the goal," investigator Frederick Raal of the University of the Witwatersrand said at the AHA meeting, according to a feature in The New York Times. The next step--and it's a big one--is to demonstrate that these drugs can work effectively for a prolonged period in a big patient population, cutting the serious risks associated with cardiovascular disease without triggering the kind of safety issues that can easily scuttle a cholesterol drug.

Yesterday, Sanofi ($SNY) and its partner Regeneron ($REGN) announced that they were starting to recruit 18,000 patients for their SAR236553/REGN727 trial, planning to provide definitive evidence of whether it can safely cut the rate of heart attacks and strokes. Sanofi and Regeneron now have 11 studies under way for their therapy, making this one of the biggest pipeline gambles in the business.

- here's the story from The New York Times
- read the Wall Street Journal report (sub. req.)
- see the story from Bloomberg

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